BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16644204 · Received March 30, 2023

    Report

    Report Number
    9611102-2023-00020
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 8, 2023
    Report Date
    May 1, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCM
    UDI-DI
    04055207043356
    PMA / PMN Number
    PRE-ENAC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H7, AND H10. THE RECTOSCOPE TUBE Ø 19MM WL 211MM 8834075, BATCH #1446330 WAS INVESTIGATED IN ACCORDANCE WITH THE TEST INSTRUCTIONS. THE DEVICE HAS SEVERE SIGNS OF USAGE SUCH AS DENTS, BUMPS AND SCRATCHES. THE METAL INSULATING CAP IS MISSING, THE USER FACILITY DID NOT RETURNED IT WITH THE REPORTED DEVICE. THE ROOT CAUSE OF THE MISSING INSULATING CAP IS MECHANICAL IMPACTS ON THE DEVICE WHICH MAY HAVE OCCURRED DURING TRANSPORT WITHIN THE USER FACILITY, DURING PREPARATION PRIOR USE, DURING USE OR IN A COMBINATION OF THESE. THE RECTOSCOPE TUBE Ø 19MM WL 211MM 8834075, BATCH #1446330 WAS MANUFACTURED ON 27/JUL/2020. THE BATCH CONSISTED OF 8 PIECES. NO ISSUES WERE IDENTIFIED DURING PRODUCTION. NO FURTHER COMPLAINTS WITH THE SAME DEVICE ISSUE WERE RECEIVED. THE IFU GA-F 043 / EN / 2013-08 V3.0 / PK18-9297 CONTAINS SAFETY INSTRUCTIONS ABOUT THE CHECKS PRIOR AND AFTER EACH USE AS WELL AS SAFETY NOTES ABOUT USE OF PREVIOUSLY DAMAGED DEVICE IN SECTION 7 CHECKS. THE SUBJECT ISSUE OF UNUSABLE DEVICE IS PRESENT IN THE RISK MANAGEMENT FILE D3: REUSABLE SHEATHS, TUBES, REV.: V00. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Description of Event or Problem · 0

    A USER FACILITY REPRESENTATIVE HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A RECTOSCOPE TUBE Ø 19MM WL 211MM, PART ID: 8834075, BATCH # 1446330. ACCORDING TO THE RECEIVED INFORMATION: "WHEN RETRACTING THE RECTOSCOPE DURING EXAMINATION, THE METAL END PIECE CAME LOOSE AND GOT STUCK IN THE RECTUM. REMOVAL OF THE END PIECE WITH PROCTOSCOPE, FORCEPS AND NEEDLE HOLDER BY DETACHING THE END PIECE. THE PROCEDURE COULD NOT BE COMPLETED DUE TO DEFECTIVE DEVICE." ACCORDING TO THE USER, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442654 NA RECTOSCOPE TUBE Ø 19MM WL 211MM GCM RICHARD WOLF GMBH 8834075 1446330 04055207043356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other